FDA Label for Bedside-care

View Indications, Usage & Precautions

Bedside-care Product Label

The following document was submitted to the FDA by the labeler of this product Coloplast Manufacturing Us, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



For Full Body Bathing and Perineal Clean-Up

Drug Facts

For external use only.


Otc - Active Ingredient



Active ingredient

Benzethonium Chloride 0.1%


Otc - Purpose



Purpose

Antiseptic


Indications & Usage



Uses Protects against the risk of bacterial contamination in minor cuts, scrapes and burns.


Warnings



Warnings


Otc - When Using



When using this product: do not use in the eyes, with deep or puncture wounds, serious burns or animal bites.


Otc - Stop Use



Stop using this product:

  • if skin irritation and redness develop
  • if condition persists for more than 72 hours, consult a physician.

Otc - Keep Out Of Reach Of Children



Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.


Dosage & Administration



Directions Cleanse the affected area according to protocol.


Inactive Ingredient



Inactive ingredients water, sodium lauroamphoacetate, cocamidopropyl betaine, glycerin, polysorbate 20, quaternium-52, citric acid, quaternium-15, fragrance, tetrasodium EDTA, green 5

Protocol: Rinsing is not required. Aids in the removal of urine, feces and other foreign material. Bathing: dispense 3-4 sprays in a basin with warm water and cleanse the skin. Shampooing: spray directly on dampened hair, lather and remove with a mois washcloth. Cleansing: apply to the affected perineal area and remove with a moist washcloth.

Manufactured by: Coloplast A/S
DK-3050 Humlebaek, Denmark
Distributed by: Coloplast Corp.
Minneapolis, MN 55411 U.S.A.
1-800-533-0464 www.us.coloplast.com
Product #1762 ©2009-2, Coloplast Corp.
Made in the U.S.A.

B9-612


Package Label.Principal Display Panel



PRINCIPAL DISPLAY PANEL - 8 fl. oz. (237 mL)

NDC 11701-020-05

Bedside-Care®

No-Rinse Cleanser

No-Rinse Body Wash, Shampoo &-Incontinent Cleanser

For Full Body Bathing and Perineal Clean-Up

Coloplast

8 fl. oz. (237 mL)


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